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SPECTRA-AFNCT07788989

A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Biosense Webster, Inc.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Oct 30, 2026 to Apr 14, 2027
    • Study completion pushed from Oct 31, 2029 to Mar 29, 2030
    • Study sites: 1 to 0
  2. Phase changed: Not specified → Not applicable Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: [Redacted] to Biosense Webster, Inc.
    • Trial status changed: Withheld → Not Yet Recruiting
    • Enrollment changed: None → 2300
    • Interventions modified
    • Trial arms changed: 0 → 2
    • Primary and study completion dates: Oct 31, 2029
    • Start date: Oct 30, 2026
    • Study title expanded, about 7 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Number of Participants with Early Onset Primary Adverse Events (PAEs)
Timeframe: Up to 7 days post-procedure
Percentage of Participants With Residual Atrial Arrhythmia (AA) Burden Based on ILR Arrhythmia Monitoring
Timeframe: Day 61 up to Day 365 post-procedure

Secondary (5)

Change in Quality of Life (QOL) As Assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=60 minutes on Implantable Loop Recorders [ILR])
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=30 seconds on ILR)
Number of Participants with Residual AA Burden <=0.1%
Percentage of Residual AA Burden

Arms and interventions

Paroxysmal Atrial Fibrillation (PAF)Experimental

Participants with symptomatic paroxysmal atrial fibrillation (PAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) utilizing the VARIPULSE catheter as per the device Instructions for Use (IFU).

Persistent Atrial Fibrillation (PsAF)Experimental

Participants with symptomatic persistent atrial fibrillation (PsAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) and posterior wall isolation (PWI) utilizing the VARIPULSE catheter as per the device IFU.

Devices: VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)